Status:
TERMINATED
Allogeneic Natural Killer (NK) Cells in Patients With Advanced Metastatic Breast Cancer
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy before a donor natural killer (NK) cell infusion helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's cells. G...
Detailed Description
We believe that administration of related allogeneic (donor) natural killer cells along with IL-2, rather than autologous natural killer cells will provide the most effective anticancer therapy in thi...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diagnosis of metastatic breast cancer that has progressed on or failed at least one salvage chemotherapy regimen for metastatic disease and that meets the following disease specific related criteria:
- Measureable metastatic disease per Response Evaluation Criteria In Solid Tumor (RECIST) - bone only not eligible.
- Disease progression while receiving prior therapy with a hormonal agent (if estrogen/progesterone receptor-positive) and/or trastuzumab (Herceptin®) (if HER2-neu positive)
- Brain metastases allowed provided they are stable for ≥ 3 months after prior treatment
- Related HLA-haploidentical natural killer cell donor available (by ≥ class I serologic typing)
- Male or female
- Performance status 50-100%
- Platelet count ≥ 80,000/mm³ (unsupported by transfusions)
- Hemoglobin ≥ 9 g/dL (unsupported by transfusions)
- Absolute neutrophil count ≥ 1,000/mm³ (unsupported by sargramostim \[GM-CSF\] or filgrastim \[G-CSF\])
- Creatinine ≤ 2.0 mg/dL
- Liver function tests \< 5 times normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- LVEF \> 40%\*
- Pulmonary function \> 50%\* (DLCO corrected AND FEV\_1)
- No active infection (i.e., afebrile, off antibiotics, and no uninvestigated radiologic lesions)
- Exclusion Criteria:
- At least 3 days since prior prednisone or other immunosuppressive medications
- No other concurrent therapy for cancer
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00376805
Start Date
April 1 2006
End Date
January 1 2010
Last Update
December 28 2017
Active Locations (1)
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1
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455